Study Status
Show Details
Description
Value
Participants Enrolled
48
Sites Enrolled
158
Study Status
Active
Nickname
Protocol Nickname
Description
Value
Participants Enrolled
48
Sites Enrolled
158
Study Status
Active
Protocol Row Id
1-1G9113
Protocol Number
AA-AA-000-0000
Protocol Title
Protocol Title
Nickname
Protocol Nickname
Protocol Type
Investigator Sponsored
Phase
P3
Num Plan Site
190
Num Site Actl
176
Est Fpfv
2003-01-01
Act Fpfv
2003-01-01
Est Lplv
2021-06-01
Act Lplv
2021-06-01
Est Lpfv
2020-06-01
Act Lpfv
2020-06-01
Status
Active
Num Plan Subj
1300
Num Enrolled Subj M
1301
Protocol Indication
Protocol Indication
Product
Product
Therapeutic Area
Therapeutic Area
Protocol Product Number
123
X Rbm Flg
Y
Study Overview
As of 2012-12-31, AA-AA-000-0000 has 48 participants enrolled across 158
sites. 93 Site-KRI combinations have been flagged across 29 sites as
shown in the Study Overview Table above.
29 sites have at least one red KRI
132 sites have at least one red or amber KRI
158 sites have neither red nor amber KRIS and are not shown
Results
Adverse Event Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X139 (el-Khalifa)
2
67
1863
0.04
-2.96
0X186 (Gallegos-Neiberger)
2
98
2518
0.04
-2.69
0X162 (Campa)
2
186
4433
0.04
-2.54
0X113 (Wilde)
3
359
8172
0.04
-2.53
0X025 (Smith)
2
136
3210
0.04
-2.04
0X155 (al-Sani)
3
379
6887
0.06
2.37
0X119 (Cousins)
3
260
4695
0.06
2.08
0X091 (Ostrom)
2
195
4462
0.04
-1.95
0X138 (Black)
2
58
1454
0.04
-1.85
0X020 (Hamlin)
3
268
5985
0.04
-1.83
0X092 (al-Badour)
3
213
4795
0.04
-1.77
0X121 (Rodriguez-Cruz)
2
111
2569
0.04
-1.61
0X148 (Suess)
2
167
3742
0.04
-1.50
0X173 (el-Yusuf)
2
200
4436
0.05
-1.47
0X013 (el-Allam)
1
96
2215
0.04
-1.46
0X164 (Jiron)
1
96
2215
0.04
-1.46
0X143 (el-Salih)
3
216
4759
0.05
-1.42
0X046 (al-Daoud)
5
432
9283
0.05
-1.42
0X016 (el-Shaker)
3
245
5366
0.05
-1.41
0X176 (Salazar)
3
285
6191
0.05
-1.36
0X105 (Patalan)
2
170
3770
0.05
-1.36
0X134 (Keese)
2
143
3165
0.05
-1.22
Serious Adverse Event Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X139 (el-Khalifa)
2
30
1863
0.02
-2.59
0X113 (Wilde)
3
170
8172
0.02
-2.50
0X186 (Gallegos-Neiberger)
2
45
2518
0.02
-2.40
0X162 (Campa)
2
90
4433
0.02
-2.07
0X157 (Arellano)
3
191
6519
0.03
2.48
0X003 (Drake)
1
59
1810
0.03
2.27
0X039 (Kimler)
1
59
1810
0.03
2.27
0X084 (Luong)
1
59
1810
0.03
2.27
0X137 (Wilson)
2
66
2105
0.03
2.06
0X046 (al-Daoud)
5
203
9283
0.02
-1.96
0X025 (Smith)
2
64
3210
0.02
-1.90
0X105 (Patalan)
2
77
3770
0.02
-1.86
0X007 (Harrison)
3
134
6250
0.02
-1.84
0X173 (el-Yusuf)
2
93
4436
0.02
-1.77
0X148 (Suess)
2
78
3742
0.02
-1.67
0X138 (Black)
2
27
1454
0.02
-1.64
0X143 (el-Salih)
3
103
4759
0.02
-1.51
0X061 (Harrison)
3
103
4676
0.02
-1.32
0X013 (el-Allam)
1
46
2215
0.02
-1.31
0X164 (Jiron)
1
46
2215
0.02
-1.31
0X092 (al-Badour)
3
106
4795
0.02
-1.29
0X134 (Keese)
2
68
3165
0.02
-1.29
0X116 (el-Ameen)
2
39
1880
0.02
-1.22
0X091 (Ostrom)
2
99
4462
0.02
-1.21
0X024 (Rinard)
3
150
6595
0.02
-1.16
0X141 (Esquibel)
2
153
6680
0.02
-1.08
0X050 (Tull)
4
164
7125
0.02
-1.05
0X166 (Garcia)
3
99
4387
0.02
-1.03
Non-Important Protocol Deviation Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X144 (el-Kaber)
1
148
2174
0.07
2.40
0X152 (Batchelder)
1
148
2174
0.07
2.40
0X161 (Vangoey)
5
573
10223
0.06
2.22
0X153 (Voss)
2
34
1440
0.02
-2.19
0X100 (Browne)
4
154
4477
0.03
-2.09
Important Protocol Deviation Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X125 (Pond)
3
133
4129
0.03
-2.30
0X086 (Gonzales)
2
256
4319
0.06
2.23
0X024 (Rinard)
3
371
6595
0.06
2.13
Grade 3+ Lab Abnormality Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X088 (Correa)
1
4
1246
0.00
-3.23
0X093 (Depoyster)
2
14
465
0.03
2.46
0X171 (Hoffpauir)
2
22
2411
0.01
-2.27
0X010 (al-Radi)
5
60
5280
0.01
-2.12
0X155 (al-Sani)
3
64
3197
0.02
2.09
0X136 (Handley)
2
16
1809
0.01
-2.06
0X103 (al-Mona)
2
35
1606
0.02
2.02
Study Discontinuation Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X153 (Voss)
2
0
9
0.00
-2.38
0X075 (Dabit)
2
22
23
0.96
2.35
0X115 (John)
1
13
12
1.08
2.29
0X024 (Rinard)
3
31
36
0.86
2.17
0X141 (Esquibel)
2
31
36
0.86
2.17
0X171 (Hoffpauir)
2
9
30
0.30
-2.14
0X121 (Rodriguez-Cruz)
2
3
15
0.20
-2.03
Treatment Discontinuation Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X091 (Ostrom)
2
20
24
0.83
2.62
0X025 (Smith)
2
16
19
0.84
2.38
0X173 (el-Yusuf)
2
19
24
0.79
2.35
0X007 (Harrison)
3
24
34
0.71
2.16
0X101 (Flood)
2
1
20
0.05
-2.13
Query Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X125 (Pond)
3
594
687
0.86
-2.53
0X141 (Esquibel)
2
1442
915
1.58
2.21
Outstanding Query Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X173 (el-Yusuf)
2
27
948
0.03
2.40
0X025 (Smith)
2
19
615
0.03
2.37
0X162 (Campa)
2
26
941
0.03
2.20
0X007 (Harrison)
3
33
1255
0.03
2.19
0X066 (Lipps)
5
15
1472
0.01
-2.15
0X091 (Ostrom)
2
26
965
0.03
2.07
0X087 (Vigo)
1
8
926
0.01
-2.05
Outstanding Data Entry Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X087 (Vigo)
1
46792
946810
0.05
-3.33
0X014 (Som)
2
29826
603929
0.05
-2.81
0X035 (el-Saladin)
2
29826
603929
0.05
-2.81
0X141 (Esquibel)
2
71565
1420199
0.05
2.36
0X133 (Pope)
1
23396
473405
0.05
-2.36
0X153 (Voss)
2
9564
187933
0.05
2.07
0X100 (Browne)
4
33054
666513
0.05
-2.01
Data Change Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X179 (Terry)
2
156
480
0.32
2.81
0X083 (el-Aman)
1
81
234
0.35
2.64
0X171 (Hoffpauir)
2
167
761
0.22
-2.62
0X105 (Patalan)
2
115
533
0.22
-2.37
X044X (Anderson)
3
219
716
0.31
2.35
0X072 (Lopez)
2
139
442
0.31
2.23
0X065 (Hill)
2
110
347
0.32
2.07
0X136 (Handley)
2
117
526
0.22
-2.03
Screen Failure Rate
Group
Enrolled
Numerator
Denominator
Metric
Score
Flag
0X030 (Hutchinson)
1
3
114
0.03
3.22
0X076 (Farr)
2
15
1419
0.01
3.22
0X006 (al-Sultana)
3
7
579
0.01
2.56
0X095 (Gonzales)
1
9
867
0.01
2.44
0X149 (Lesley)
2
7
678
0.01
2.13
0X016 (el-Shaker)
3
12
1461
0.01
2.02
Metric Details
MetricID
File
GroupLevel
Abbreviation
Metric
Numerator
Denominator
Model
Score
Type
Threshold
nMinDenominator
kri0001
kri0001.yaml
Site
AE
Adverse Event Rate
Adverse Events
Days on Study
Normal Approximation
Adjusted Z-Score
rate
-2,-1,2,3
30
kri0002
kri0002.yaml
Site
SAE
Serious Adverse Event Rate
Serious Adverse Events
Days on Study
Normal Approximation
Adjusted Z-Score
rate
-2,-1,2,3
30
kri0003
kri0003.yaml
Site
PD
Non-Important Protocol Deviation Rate
Non-Important Protocol Deviations
Days on Study
Normal Approximation
Adjusted Z-Score
rate
-3,-2,2,3
30
kri0004
kri0004.yaml
Site
PD
Important Protocol Deviation Rate
Important Protocol Deviations
Days on Study
Normal Approximation
Adjusted Z-Score
rate
-3,-2,2,3
30
kri0005
kri0005.yaml
Site
LB
Grade 3+ Lab Abnormality Rate
Grade 3+ Abnormal Labs Samples
Total Lab Samples
Normal Approximation
Adjusted Z-Score
binary
-3,-2,2,3
30
kri0006
kri0006.yaml
Site
SDSC
Study Discontinuation Rate
Subjects Discontinued - Study
Enrolled Subjects
Normal Approximation
Adjusted Z-Score
binary
-3,-2,2,3
3
kri0007
kri0007.yaml
Site
TDSC
Treatment Discontinuation Rate
Subjects Discontinued - Treatment
Enrolled Subjects
Normal Approximation
Adjusted Z-Score
binary
-3,-2,2,3
3
kri0008
kri0008.yaml
Site
QRY
Query Rate
Queries
Total Data Points
Normal Approximation
Adjusted Z-Score
rate
-3,-2,2,3
30
kri0009
kri0009.yaml
Site
OQRY
Outstanding Query Rate
Queries Open > 30 Days
Total Queries
Normal Approximation
Adjusted Z-Score
binary
-3,-2,2,3
30
kri0010
kri0010.yaml
Site
ODAT
Outstanding Data Entry Rate
Data Pages Entered > 10 Days
Total Data Pages
Normal Approximation
Adjusted Z-Score
binary
-3,-2,2,3
30
kri0011
kri0011.yaml
Site
CDAT
Data Change Rate
Data Points with 1+ Change
Total Data Points
Normal Approximation
Adjusted Z-Score
binary
-3,-2,2,3
30
kri0012
kri0012.yaml
Site
SF
Screen Failure Rate
Screen Failures
Screened Subjects
Normal Approximation
Adjusted Z-Score
binary
-3,-2,2,3
3